1. Field of the Invention
This invention relates generally to medical procedures and apparatus; and more particularly to refinement of such procedures and apparatus for treating stress incontinence in women by pubovaginal suspension without surgery.
2. Prior Art
Ruben F. Gittes and Kevin R. Loughlin have introduced "a modified needle suspension for urinary incontinence that eliminates all incisions." 138 The Journal of Urology 568-70 (1987). In their method, as described in an abstract:
"The anterior vaginal wall is suspended from the rectus fascia with 2 heavy nonabsorbable monofilament mattress sutures. The sutures pass down through and back up through the full thickness of the vaginal wall, and are tied suprapubically to bury the knot into the fat in the suprapubic puncture site . . . [M]onofilament mattress sutures that are tied under tension to include the outside abdominal skin will cut through the skin, and become internalized and accepted without any residual inflammation if the knot is buried initially. . . . " PA0 "makes routine use of outpatient surgery and allows for the use of local anesthesia only in selected patients. At 21/2 years the continence rate in the first 38 patients exceeded 87 percent. There were no failures among the last 14 patients after the technique was modified to include an extra full thickness pass of the mattress suture through the vaginal wall. There have been no significant complications." PA0 "A special long mattress-type needle is needed. . . . A small puncture is made . . . into the suprapubic fat pad. . . . The long needle is popped through the rectus fascia and the anteriorly deflected tip is advanced carefully down the posterior aspect of the pubic bone. At the same time, the operator's second hand elevates the anterior vaginal wall lateral to the Foley balloon, thus, just lateral to the bladder neck. Wiggling the needle from above and directing it toward the fingertip by rocking forward the suprapubic portion of the needle shaft avoids a false passage into the bladder or past the lateral vaginal wall. While controlling the tip of the needle with the tip of the finger, the operator examines the tented-up vaginal wall to make sure it is not too medial or lateral, and then the tip is popped through the wall and then forward through the introitus." Id. at 568. PA0 "Before the suspending sutures are tied down, cystourethroscopy must be done to rule out damage to the bladder wall by the sutures and to place a percutaneous suprapubic [cystostomy] under endoscopic control. The 70-degree telescope allows for close inspection of the bladder wall just inside the bladder neck. If any part of either suture is [seen], either perforating the bladder or even coursing submucosally, that arm of the suture is identified by traction, pulled out into the vagina and replaced upward with a new pass of the mattress needle. In difficult cases, as in bladders widely fixed anteriorly by the Burch modification of the Marshall-Marchetti operation, the passage of the needle can be monitored continuously endoscopically with the 120-degree telescope." PA0 (1) inserting a urethral trocar into the woman's bladder and therethrough to press outward firmly against the woman's abdominal wall, so as to be perceptible from the exterior of the woman's body; PA0 (2) then, with the exteriorly perceptible trocar as a guide, making a suprapubic incision in the woman's abdominal wall and bladder to gain access to a tip of the trocar; PA0 (3) then using the tip of the trocar directly or indirectly to guide a tip of a viewing device through the suprapubic incision and into the woman's bladder; and PA0 (4) then installing sutures between the woman's rectus fascia and vagina, by means of a needle inserted through the woman's abdomen and into the woman's vagina; PA0 (5) substantially during the suture-installing step, monitoring the interior of the bladder through the viewing device to avoid placement of sutures in the bladder wall--so that the viewing device is remote from the neck of the bladder, where inadvertent placement of sutures is particularly likely; and PA0 (6) substantially during the suture-installing and monitoring steps, maneuvering the trocar or the viewing device, or both, to manipulate tissues of the woman's bladder, urethra, or abdominal wall, or combinations of any of these tissues, to facilitate accurate placement of the sutures, particularly avoiding the bladder and urethra.
The Gittes and Loughlin procedure evidently provides significant benefits for patients. As also pointed out in the abstract, this procedure:
Without detracting in the least from these potential benefits, it is important to recognize significant limitations in the reported procedure. First, it calls for significant manual dexterity, as well as a visualization capacity approaching the clairvoyant, on the part of the physician:
With dexterity and experience, and great care, this procedure undoubtedly can be performed reliably. None of these characteristics, however, can be guaranteed, as Gittes and Loughlin in effect concede:
Although Gittes and Loughlin go on to recommend using a suprapubic "puncture" later for placement of a "suprapubic tube of the trocar variety"--for postprocedure drainage--they clearly do not use that puncture for placement of a viewing device for the monitoring step.
From their discussion it is evident that they instead insert an endoscope through the urethra. Their suprapubic drain is installed in a puncture made from the outside while watching the anterior bladder wall from within. That procedure is only a slight improvement on the conventional method, which employs a large trocar inserted suprapubically from above, blind--that is, puncturing the abdominal wall and bladder from the exterior, without any guidance.
The latter method is extremely dangerous and in fact potentially lethal--especially if the patient's anatomy is abnormal, as for example can occur as a result of previous surgery, leaving, e.g., the patient's bowel ventral to the bladder. The improvement gained by the procedure of Gittes and Loughlin is only slight, because watching the anterior bladder wall from within the bladder affords only a fairly rough view of the entry point, and of the bladder configuration and position relative to the abdomen.
The methods described by Gittes and Loughlin are derived from a technique introduced in 1973 by T. A. Stamey, 136 Surg., Gynec. & Obst. 547. An early modification by J. T. Mason and R. M. Soderstrom, 6 Urology 233 (1975) provided for suprapubic monitoring of needle placement, by means of a rigid cystoscope inserted through a Foley catheter that had been modified for the purpose.
In my opinion, although I have seen nothing in the prior art to support my opinion, that approach should be considered a major improvement. The reason is that using a urethroscope--whether it be a 70-degree or 120-degree instrument--to monitor the needle passage has important drawbacks, as follows.
The area of greatest concern with respect to inadvertent puncture of the vesical wall is the neck of the bladder, for the very reason that the neck is the portion to be elevated, and is immediately adjacent to the vaginal wall--the target of the needles. In other words, it is in this region that the needles must be brought closest; but this is precisely the spot at which the 'scope itself is introduced. The urethroscope is not only immediately adjacent to the neck of the bladder, but also mechanically coupled to the neck of the bladder in a somewhat complicated and unpredictable way.
Hence the practitioner is faced with difficult demands, to say the least, upon dexterity. The objective is to somehow position the urethroscope for best viewing of the immediately adjacent bladder neck, without actively making matters worse by inadvertently pushing the neck itself toward the advancing needle tip.
In many cases these two constraints seem to be mutually inconsistent. Yet Gittes and Loughlin evidenced no appreciation in their 1987 paper for the advance introduced long earlier by Mason and Soderstrom.
Very recently, however, Loughlin has proposed, 142 J. Urology 1532 (1989), to update the Mason and Soderstrom modification. (Loughlin's work is not deemed to be prior art with respect to the present document.) Loughlin now substitutes a flexible ureteroscope for the cystoscope, thereby facilitating continuous observation of the bladder wall and neck during passage of the needles. Still, neither Mason and Soderstrom nor Loughlin has offered anything to mitigate the hazards of introducing the viewing device by a blind puncture.
In another area of prior practice, the present inventor some twenty years ago introduced certain procedures and instrumentation for introducing suprapubic catheters without the potentially lethal use of a large trocar in blind insertion. See U.S. Pat. Nos. 3,640,281 and 3,656,486 (both filed 1970); and "Suprapubic Cystostomy with Endoscopy" 41 Obstetrics-Gynecology 624-27 (1973).
The system there described is not in prevalent use today, and Gittes and Loughlin make no reference to it. It provides a trocar that is inserted through the urethra, into the bladder, and against the bladder lining and abdominal wall from within; the resulting acute bulge at the exterior of the patient's abdomen is then used by the physician to identify the proper point for a small puncture. The puncture itself is preferably made from the exterior, against the tip of the trocar that is within.
The trocar is then preferably passed through that puncture outward, from within the bladder, and attached outside the body to a catheter or other instrument. Alternatively the trocar need not be actually passed out from the abdomen but can be attached to the catheter or other instrument while lying just within the puncture.
The trocar motion is then reversed to draw the trocar and external instrument through the puncture and into the bladder. Thereupon the trocar can be forthwith disconnected and withdrawn from the urethra, or can be temporarily kept in place for other purposes such as inflation of the bladder.
To facilitate connection and later disconnection of the trocar and the catheter or other instrument, the trocar was fashioned with either a hook, in a lateral recess near its end, or an aligning socket in its tip.
The present inventor also introduced a method and apparatus for facilitating endoscopy through obturation by means of gas--described in U.S. Pat. No. 3,709,214 (filed 1971). The system there described involves placing a gas-obturating endoscope into bodily cavities or organs such as the bladder; and particularly in the case of the bladder involves placement through the urethra.
Gas obturation provides less trauma than mechanical obturation, less cumbersomeness and discomfort than liquid inflation, and a clearer view than either. This system is in somewhat greater use modernly, but also not mentioned by Gittes and Loughlin--or even in Loughlin's most recent paper reintroducing suprapubic viewing.